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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03850483




Registration number
NCT03850483
Ethics application status
Date submitted
20/02/2019
Date registered
21/02/2019
Date last updated
29/06/2022

Titles & IDs
Public title
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
Scientific title
A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM APPLIED ONCE OR TWICE DAILY FOR 12 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Secondary ID [1] 0 0
2018-003051-38
Secondary ID [2] 0 0
B7931023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06700841
Treatment: Drugs - Vehicle (Placebo)

Placebo comparator: Vehicle cream QD - Vehicle cream applied once daily (QD)

Experimental: PF-06700841 0.1% cream QD - PF-06700841 0.1% cream applied once daily (QD)

Experimental: PF-06700841 0.3% cream QD - PF-06700841 0.3% cream applied once daily (QD)

Experimental: PF-06700841 1% cream QD - PF-06700841 1% cream applied once daily (QD)

Experimental: PF-06700841 3% cream QD - PF-06700841 3% cream applied once daily (QD)

Experimental: PF-06700841 0.3% cream BID - PF-06700841 0.3% cream applied twice daily (BID)

Experimental: PF-06700841 1% cream BID - PF-06700841 1% cream applied twice daily (BID)

Placebo comparator: Vehicle cream BID - Vehicle cream applied twice daily (BID)

Experimental: PF-06700841 3% cream BID - PF-06700841 3% cream applied twice daily (BID)


Treatment: Drugs: PF-06700841
PF-06700841 topical cream

Treatment: Drugs: Vehicle (Placebo)
Vehicle topical cream
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Timepoint [2] 0 0
Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Secondary outcome [3] 0 0
Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Timepoint [3] 0 0
Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Secondary outcome [4] 0 0
Change From Baseline in PASI Scores at Week 14 and 16
Timepoint [4] 0 0
Baseline, Week 14 and 16
Secondary outcome [5] 0 0
Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12
Timepoint [5] 0 0
Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Secondary outcome [6] 0 0
Percent Change From Baseline in PASI Scores at Week 14 and 16
Timepoint [6] 0 0
Baseline, Week 14 and 16
Secondary outcome [7] 0 0
Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Timepoint [7] 0 0
Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Secondary outcome [8] 0 0
Absolute PP-NRS Score at Week 14 and 16
Timepoint [8] 0 0
Week 14 and 16
Secondary outcome [9] 0 0
Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12
Timepoint [9] 0 0
Baseline, Week 1, 2, 4, 6, 8, 10 and 12
Secondary outcome [10] 0 0
Change From Baseline in PP-NRS Score at Week 14 and 16
Timepoint [10] 0 0
Baseline, Week 14 and 16
Secondary outcome [11] 0 0
Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2
Timepoint [11] 0 0
Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET)
Secondary outcome [12] 0 0
Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2
Timepoint [12] 0 0
Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET)
Secondary outcome [13] 0 0
Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16
Timepoint [13] 0 0
Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16
Secondary outcome [14] 0 0
Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Timepoint [14] 0 0
Week 1, 2, 4, 6, 8, 10, 12, 14, and 16
Secondary outcome [15] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs
Timepoint [15] 0 0
Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Secondary outcome [16] 0 0
Number of Participants With TEAEs by Severity
Timepoint [16] 0 0
Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Secondary outcome [17] 0 0
Number of Participants Who Discontinued From Study Due to Adverse Events
Timepoint [17] 0 0
Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Secondary outcome [18] 0 0
Number of Participants With Laboratory Abnormalities Meeting Specified Criteria
Timepoint [18] 0 0
Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Secondary outcome [19] 0 0
Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data
Timepoint [19] 0 0
Post-baseline to Week 6, Post-baseline to Week 12
Secondary outcome [20] 0 0
Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Timepoint [20] 0 0
Post-baseline to Week 12
Secondary outcome [21] 0 0
Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16
Timepoint [21] 0 0
Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16

Eligibility
Key inclusion criteria
* plaque psoriasis for 6 months
* PGA score mild or moderate
* body surface area (BSA) 2-15%
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* other skin conditions that would interfere with the evaluation of psoriasis
* history of herpes zoster or simplex
* Infected with Mycobacterium tuberculosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/04/2021
Sample size
Target
Accrual to date
Final
344
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [2] 0 0
Emeritus Research - Camberwell
Recruitment hospital [3] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [4] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Canada
State/province [20] 0 0
Manitoba
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Denmark
State/province [23] 0 0
Hellerup
Country [24] 0 0
Germany
State/province [24] 0 0
Bad Bentheim
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Bielefeld
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Mahlow
Country [30] 0 0
Germany
State/province [30] 0 0
Schwerin
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Debrecen
Country [33] 0 0
Hungary
State/province [33] 0 0
Kecskemet
Country [34] 0 0
Hungary
State/province [34] 0 0
Szeged
Country [35] 0 0
Japan
State/province [35] 0 0
Hokkaido
Country [36] 0 0
Japan
State/province [36] 0 0
Osaka
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Latvia
State/province [38] 0 0
Riga
Country [39] 0 0
Latvia
State/province [39] 0 0
Ventspils
Country [40] 0 0
Poland
State/province [40] 0 0
Bialystok
Country [41] 0 0
Poland
State/province [41] 0 0
Torun
Country [42] 0 0
Poland
State/province [42] 0 0
Warszawa
Country [43] 0 0
Poland
State/province [43] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.
Trial website
https://clinicaltrials.gov/study/NCT03850483
Trial related presentations / publications
Forman SB, Pariser DM, Poulin Y, Vincent MS, Gilbert SA, Kieras EM, Qiu R, Yu D, Papacharalambous J, Tehlirian C, Peeva E. TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. J Invest Dermatol. 2020 Dec;140(12):2359-2370.e5. doi: 10.1016/j.jid.2020.03.962. Epub 2020 Apr 18.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03850483